On an eventful Friday in the blood pressure and heart medication world, two companies recalled more medications, one because of a new possibly cancer-causing impurity that’s got the FDA “deeply concerned.”
That new could-be carcinogen, N-Methylnitrosobutyric acid (NMBA), caused Camber Pharmaceuticals to recall an additional 87 lots of Losartan potassium tablets Thursday. Friday, Torrent recalled 60 lots of Losartan potassium tablets and 54 lots of Losartan potassium/hydrochlorothiazide tablets because of NMBA’s presence. The active ingredient in each came from India-based Hetero Labs Limited.
The previous recalls of Losarta, Valsartan or Irbesartan involved too much N-Nitrosodiethylamine (NDEA) or N-nitrosodimethylamine (NDMA).
“We are deeply concerned about the presence of a third nitrosamine impurity in certain ARB (angiotensin II receptor blocker) medications,” FDA Commissioner Scott Gottlieb said in Friday’s update on the problem, “but it’s important to underscore that, based on the FDA’s initial evaluation, the increased risk of cancer to patients with NMBA exposure appears to be the same for NDMA exposure but less than the risk from NDEA exposure.
“That said, any presence of such impurities in drug products is not acceptable.”
AurobindoPharma, which recalled 80 lots of Valsartan medicines that had too much NDEA in January, added another 38 lots of Valsartan and Valsartan with Amlodipine tablets Friday. The medicines also were distributed under the name “Acetris Health.” They were made either in India or by Aurolife Pharma in Dayton, New Jersey.
Friday’s update from the FDA also included the reminder “patients taking an ARB medication from a recalled lot (should) continue taking their medicine until their doctor or pharmacist provides a replacement or a different treatment option.”
Torrent customers with questions can email MedInfo.email@example.com or call 800-912-9561, which is answered live 8 a.m. to 5 p.m. and has voicemail the rest of the time.
Aurobindo customers with questions or who want to report problems with the medication can call 866-850-2876 and take Option No. 2 or email firstname.lastname@example.org.
For a full list of all Losartan medications under recall click here.
For a full list of all Valsartan medications under recall click here.
For a full list of all Irbesartan medications under recall click here.